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Bio-Techne Expanding in Clinical Diagnostic Market With Ella Immunoassay Instrument


NEW YORK – Bio-Techne's flagship Ella immunoassay analyzer will soon be available for an entirely new set of customers as the company expands the market for the instrument to clinical diagnostics. 

With more than 1,000 instruments installed globally, the platform has a significant existing customer base, but the Minneapolis-based company is broadening its reach beyond the research market. 

Thus far, uptake has been strongest in North America, although Europe has also had strong uptake, especially in university hospitals, said Steve Crouse, the company's senior VP and GM for the analytical solutions division. Contract research organizations supporting clinical trials and cell and gene therapy companies have also adopted the instrument, which is sold under Bio-Techne's ProteinSimple business. There are also some customers using the platform for laboratory-developed tests to understand immune response, such as in transplant rejection.

But with the receipt of ISO 13485 certification at its Wallingford, Connecticut-based facility last month, Bio-Techne is prepared to support Ella applications in the clinical diagnostics space. The standard creates a quality system framework for the design, development, and manufacturing of medical devices to ensure their safety and effectiveness, and to receive certification a company must show that critical components are designed and manufactured to meet customer and regulatory requirements.

The platform can be used in multiple configurations from single-plex to eight-plex and with up to 72 samples, Crouse said. It has a 90-minute turnaround time and is “ideal for settings where data integrity, data quality really matters,” such as in clinical trials for biomarkers or quality control release for cell therapy assays, he said. 

The microfluidics within the assay cartridge can be used to select the appropriate sample volume so pipetting errors or other sample preparation issues don’t affect the final data, he added. The company also provides a factory-calibrated standard curve to eliminate any potential variability in pipetting or other steps. The company has “focused on reproducibility as a core tenet both in instrument manufacturing and assay manufacturing,” he said. 

The firm is already prepared for its first commercial regulatory-approved diagnostic assay on Ella, which is expected to launch in India in the first half of 2024 and then expand to Europe and North America. The test measures inflammation in the eye to help prevent complications during LASIK surgery, and some of the markers may also be used to understand ocular disease, Crouse said. 

Bio-Techne is also working with partners to determine where the platform will have the most use and is exploring applications in neurology, such as traumatic brain injury, and immune response, such as sepsis or acute respiratory distress syndrome (ARDS), Crouse said. Determining the severity of brain injuries and understanding the immune response during sepsis are areas of interest, he added, as is cancer.

The focus is on areas where "underlying biology of the patient's condition … can inform the specific treatment," Crouse said. "We're trying to anticipate where there might be value."

The company has "more interest in being able to assess patients and how they're responding on a biological level to direct treatment," he noted. The firm has multiple ongoing clinical studies covering a variety of diseases, including sepsis and ARDS, and how treatment for those diseases can be informed, he said. It has also developed tests for a variety of neuroscience biomarkers, including neurofilament light and phosphorylated tau, as well as tests for inflammatory markers like C-reactive protein and interferon-gamma. 

Understanding the pathology of immune response has also been of interest to Bio-Techne and its partners because it is "really valuable in being able to direct the treatment decisions," he said. 

Bio-Techne is not currently planning to develop its own diagnostics to sell, however, but rather aims to work with partners who are looking to clinically validate their tests on Ella. Those partners are groups "that have identified potential diagnostic parameters that protein diagnostics are ideal for," he said. 

The company has an existing clinical diagnostic sales organization under its Asuragen business and is exploring other direct distribution opportunities, but that is "currently not our strategy," Crouse said. Instead, customers will likely create their own distribution channels and commercial organizations to sell the tests to the clinical market. 

"What we're doing is putting ourselves in a position to deliver highly reproducible assays and manufacture them at scale," he said. Manufacturing will remain at the Wallingford facility, he noted.

Bio-Techne already has a portfolio of more than 200 validated Simple Plex assays that can be taken through clinical validation, Crouse said, but the company can also work with partners on custom development and adding new analytes to existing tests. 

"Nine times out of 10, we already have the assays of interest to move forward," he said. Partners, including other companies and research teams, can buy an assay and the instrument and take it through their own clinical validation. As the partners move through the regulatory process and build data for regulatory filings, Bio-Techne can further support them, but the partners themselves will build up their own commercial organizations. 

The instrument is validated for use with plasma, cell-culture fluids, cerebrospinal fluid, and serum. The company is "still working through" whether it will further develop Ella as a full point-of-care instrument, which would likely require the platform to be validated for use with whole blood samples. The instrument, as it stands now, is appropriate for use in near-patient settings, such as hospital laboratories, as it requires little hands-on expertise, he said. 

There has been "good interest" in the instrument itself for clinical diagnostic applications, Crouse said, but validating the use case for protein diagnostics is a longer process.

"Understanding where protein diagnostics can have a meaningful impact on treatment decisions and become a paradigm for how these decisions are made, that's taking time to build datasets and build the right information to validate that there's a clinical strategy that makes both financial and therapeutic sense," he said.